Challenges in Regulatory Acceptance of Digital Biomarkers
Challenges in Regulatory Acceptance of Digital Biomarkers Overcoming Regulatory Barriers to Digital Biomarkers in Clinical Trials Introduction: The Promise and Pitfalls of Digital Biomarkers Digital biomarkers—quantitative, objective physiological or behavioral data captured via digital devices—offer immense promise in clinical trials. From gait speed to heart rate variability and sleep fragmentation, these measures provide a continuous,…
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